510(k) · Cleared
ClearedDana 3CC Syringe Insulin Reservoir
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sooil Development Co., Ltd. · MRZ Accessories, Pump, Infusion
Cleared on Sep 4, 2007 as substantially equivalent to K001604 (Sooil Development Co., Ltd., 2000) and 4 other predicates after a 105-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Sep 4, 2007
- Review
- 105 days
- Class
- Class II
- Product code
- MRZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K991936 (2000). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK991936 3.0 ML Reservoir, Model 103/193Medtronic Minimed · 2000
- 2 generations backK013767 Simplicity Infusion Reservoir for Use to Infuse Medicine, Including…Sterling Medivations, Inc. · 2001
- 1 generation backK051045 Simplechoice 3.0 ML Reservoir Pro Reference Number RP-30Spectrx, Inc. · 2005
- This deviceK071418 Dana 3CC Syringe Insulin ReservoirSooil Development Co., Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991936 | 3.0 ML Reservoir, Model 103/193 | Medtronic Minimed | 2000 | — |
| −2 | K013767 | Simplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin… | Sterling Medivations, Inc. | 2001 | — |
| −1 | K051045 | Simplechoice 3.0 ML Reservoir Pro Reference Number RP-30 | Spectrx, Inc. | 2005 | — |
| 0 (this device) | K071418 | Dana 3CC Syringe Insulin Reservoir | Sooil Development Co., Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MRZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MRZ device
- #1 K193654 BlueStar Rxscore 7.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001604 | Dana DiabecareSummary page 1…Insulin c ificaon Name: Accessories, infusionpump 3. PREDICATE DEVICES SOMLDevelopment Co., Ltd., DANA Diabecare® (K001604)* · Spectrx, Inc., SimpleChoice 3.0 ml Reservoir Pro (K051045) Applied Diabetes Research, Inc., SureSet 3.0 m… | 2000 |
| * | K051045 | Simplechoice 3.0 ML Reservoir Pro Reference Number RP-30Summary page 1…essories, infusionpump 3. PREDICATE DEVICES SOMLDevelopment Co., Ltd., DANA Diabecare® (K001604)* · Spectrx, Inc., SimpleChoice 3.0 ml Reservoir Pro (K051045) Applied Diabetes Research, Inc., SureSet 3.0 ml Reservoir… | 2005 |
| * | K024056 | Sureset 3.0 ML Reservoir, Model 24-103Summary page 1…oice 3.0 ml Reservoir Pro (K051045) Applied Diabetes Research, Inc., SureSet 3.0 ml Reservoir (K024056) Sterling Medivations, Inc., Simplicity Infusion Reservoir (K013… | 2003 |
| * | K013767 | Simplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin, From an…Summary page 1…(K024056) Sterling Medivations, Inc., Simplicity Infusion Reservoir (K013767) Medtronic MiniMed, Inc., 3.0 ml Reservoir Model 103/193 (K9919… | 2001 |
| * | K991936 | 3.0 ML Reservoir, Model 103/193Summary page 1…(K013767) Medtronic MiniMed, Inc., 3.0 ml Reservoir Model 103/193 (K991936) *Insulinreservoir accessory included in KOO 1604 ~4'DEVICE DESCRIPTION The DANA 3cc Syringe Insulin Reservoir is a sterile,… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K001604.
How does its category compare?
All MRZ devicesMRZ Accessories, Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MRZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MRZ
96in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRZ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRZ
35in 2025
MAUDE reports naming product code MRZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 4 | 96 | 0 | 0 |
| 2009 | 2 | — | 1 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 117 |
| 2016 | 2 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 18 |
| 2018 | 1 | — | 1 | 46 |
| 2019 | 1 | — | 5 | 36 |
| 2020 | 2 | — | 0 | 44 |
| 2021 | 1 | — | 0 | 61 |
| 2022 | 1 | — | 0 | 39 |
| 2023 | 1 | — | 0 | 27 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DANA 3cc Syringe Insulin Reservoir is an accessory to the DANA Diabecare® Insulin Pumps. The DANA 3cc Syringe Insulin Reservoir is intended for the delivery of insulin from the DANA Diabecare® Insulin Pumps using specified insulin administration sets.
The DANA 3cc Syringe Insulin Reservoir is intended exclusively for use with the DANA Diabecare® Insulin Pumps. The DANA Diabecare® Insulin Pumps are external programmable syringe infusion pumps used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pumps are not intended for use with blood or blood products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071418: Dana 3CC Syringe Insulin Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071418
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026